RESUMO
BACKGROUND AND OBJECTIVE: In July, 2002, observational post-authorization studies were subjected to regulation in Spain, giving rise to an uproar among sponsors and investigators. The aim of the present report was to assess the scientific and ethical quality of the studies presented during the year before the regulation came into force. In addition, we explored how many of them reached publication. MATERIAL AND METHOD: We extracted information relative to administrative procedures, methods, follow-up and ethical issues from the protocol of the studies presented to the Spanish Agency for Medicines and Healthcare Products (AEMPS) during 2001. RESULTS: A total of 162 studies intended to recruit 306,539 patients were registered as post-authorization studies in 2001. The most widely used design was the <
Assuntos
Pesquisa Biomédica/normas , Ensaios Clínicos como Assunto/normas , Humanos , Controle de Qualidade , Sistema de Registros , Projetos de Pesquisa , EspanhaAssuntos
Legislação de Medicamentos , Vigilância de Produtos Comercializados , Ensaios Clínicos como Assunto/economia , Ensaios Clínicos como Assunto/legislação & jurisprudência , Ensaios Clínicos como Assunto/normas , Comissão de Ética , Humanos , Vigilância de Produtos Comercializados/economia , Vigilância de Produtos Comercializados/normas , Estudos Prospectivos , Projetos de Pesquisa/normas , EspanhaRESUMO
BACKGROUND: Safety profiles of classical and new antidepressants are well established. Hepatotoxicity is known to occur. Recently, several cases of severe hepatic injury associated with the new antidepressants have been reported, prompting us to quantify this risk. METHOD: To estimate the cumulative incidence of hepatic adverse reactions associated with antidepressants, we used cases of hepatic damage collected via spontaneous reporting and included in the Spanish Pharmacovigilance System database; for exposure, we have used data from drug sales to the Spanish National Health System. RESULTS: The estimated reported incidence did not show major differences for the antidepressants studied, ranging from 1.28 cases per 100,000 patient-years for sertraline to 4.00 for clomipramine, except for nefazodone, which was the agent that had the highest incidence with 28.96 cases per 100,000 patient-years. CONCLUSION: The reported incidence of hepatic adverse reactions to nefazodone seems to be higher than that estimated so far. Given the high prevalence of depression and the widespread use of antidepressants, physicians should be alert to the possibility that these medications cause hepatitis and consider early discontinuation of an antidepressant if the condition is suspected.
Assuntos
Antidepressivos/efeitos adversos , Doença Hepática Induzida por Substâncias e Drogas , Transtorno Depressivo/tratamento farmacológico , Triazóis/efeitos adversos , Adulto , Idoso , Antidepressivos/uso terapêutico , Doença Hepática Induzida por Substâncias e Drogas/diagnóstico , Doença Hepática Induzida por Substâncias e Drogas/epidemiologia , Doença Hepática Induzida por Substâncias e Drogas/etiologia , Monitoramento de Medicamentos , Feminino , Humanos , Incidência , Hepatopatias/diagnóstico , Hepatopatias/epidemiologia , Piperazinas , Inibidores Seletivos de Recaptação de Serotonina/efeitos adversos , Inibidores Seletivos de Recaptação de Serotonina/uso terapêutico , Índice de Gravidade de Doença , Triazóis/uso terapêuticoRESUMO
OBJECTIVES: In the last few years there have been changes in the pattern of consumption of antihypertensive drugs in Spain. This study aimed to describe the pattern of use in Spain from 1995 to 2001, its compliance with guidelines, and its economic impact. An aim of particular interest for our study was the impact of angiotensin II receptor antagonists on the consumption of the drugs from other therapeutic subgroups. PATIENTS AND METHOD: Information on drug utilization was obtained from the ECOM database of the Spanish Ministry of Health, which records the number of packages charged to the National Health System. Data were expressed in defined daily dose (DDD) and DDD per 1000 inhabitants per day (DHD). RESULTS: Antihypertensive consumption in Spain increased from 113.1 DHD in 1995 to 182.8 in 2001 (an increase of 61.65%). In 2001, angiotensin II receptor antagonists accounted for 25% of the costs and 14% of the consumption. Overall, costs increased from 646.42 million euros in 1995 to 1144.77 million euros in 2001. CONCLUSIONS: The consumption of antihypertensive drugs in Spain has increased remarkably in the last 7 years. Likewise, costs have increased proportionately, although the contributions of different therapeutic subgroups have been unequal. The impact of angiotensin II receptor antagonists has been considerable, both on consumption and on costs.
Assuntos
Anti-Hipertensivos/uso terapêutico , Hipertensão/tratamento farmacológico , Anti-Hipertensivos/economia , Custos e Análise de Custo , Uso de Medicamentos/estatística & dados numéricos , Humanos , Hipertensão/economia , Hipertensão/epidemiologia , Espanha/epidemiologiaRESUMO
BACKGROUND: The consumption of hormonal replacement therapy (HRT) in Spain is not known. Therefore, we have conducted a study to know the mean features of that consumption and to find out the prevalence of use among women older than 40. SUBJECTS AND METHOD: To know the consumption, we have used the information contained in ECOM database from the Ministry of Health regarding medicines sold to the Spanish Health System. Also, data gathered by the General Practitioner Sentinel Network of Castilla y León had been used. The data of consumption are presented in daily defined dose per 1000 women more than 40 years (DHD); prevalence of use per year and for ages was also estimated. RESULTS: The HRT consumption in Spain throughout the National Health System was 6,94 DHD in 1989 and 39.92 DHD in 1999. The percentage of women using this therapy was 0.7% in 1989 and 3,4 in 1999; the group 50-54 years had the highest prevalence of use, 10,84% (IC 95%, 10.66-11.01). CONCLUSIONS: The release into the market of those transdermal forms of HRT facilitated an increase in the consumption. Nonetheless, the proportion of postmenopausal women on HRT in Spain is lower than that of the other countries from the European Union. The proportion of women treated with estrogens and progestins is also small compared with current recommendations.
Assuntos
Terapia de Reposição de Estrogênios/estatística & dados numéricos , Estrogênios , Pós-Menopausa/fisiologia , Adulto , Feminino , Humanos , Pessoa de Meia-Idade , Prevalência , EspanhaRESUMO
BACKGROUND: Recent studies have revealed a rise in the use of anxiolytic and hypnotic drugs as well as the improper use thereof in Western countries. This study is aimed at ascertaining the pattern of use of anxiolytic and hypnotic drugs in Spain within the 1995-2002 period. METHODS: The data related to the use of medications was taken from the Ministry of Health and Consumer Affairs' ECOM (Medicinal Products Consumption) database, which includes information on the use of medications delivered through the community pharmacies and reimbursed by the National Health System. The data are expressed in Defined Daily Doses per 1,000 inhabitants per day. RESULTS: The use of anxiolytic and hypnotic drugs rose from 39.71 Defined Daily Doses per 1,000 inhabitants per day in 1995 to 62.02 in 2002. Throughout the period under study, benzodiazepines having a medium-range half-life (8-24 h.) were those most used, especially lorazepam, alprazolam and lormetazepam. The active ingredient having shown the greatest drop in use was flunitrazepam. CONCLUSIONS: Although the use of anxiolytic and hypnotic drugs has undergone a considerable rise in recent years in Spain, the pattern of use has shown no major changes.
Assuntos
Ansiolíticos , Revisão de Uso de Medicamentos , Hipnóticos e Sedativos , Bases de Dados como Assunto , Humanos , EspanhaRESUMO
BACKGROUND: Over the past ten years, new drugs and new approaches to treatment have been implemented making it possible to assume changes in the use of antipsychotic drugs in our environment. This study is aimed at characterizing the pattern of use of antipsychotic drugs in Castile and Leon throughout the 1990-2001 period as well as ascertaining the bearing which the marketing of new antipsychotic drugs may have had on the pattern of consumption of these drugs. METHODS: The drug consumption data was obtained from the Ministry of Health and Consumer Affairs' consumption database ECOM (Especialidades Consumo de Medicamentos). This database contains information on the consumption of medications dispensed charged to the Social Insurance system in community pharmacies nationwide. To estimate the consumption outside of the National Health System, data from the IMS (International Marketing Services) firm for the years 2000 and 2001 was used. The data was given in Defined Daily Doses/1000 inhabitants/day. RESULTS: The use of antipsychotic drugs rose by 146% within the 1990-2001 period. Throughout the period studied, haloperidol was the antipsychotic drug most used in Spain and in Castile and Leon. The atypical antipsychotic drugs totaled 49% of the total consumption for 2001 and 90% of the costs, a strong trend being found toward an increase in the consumption of these atypical antipsychotic drugs in detriment to the typical antipsychotic drugs. It has been estimated that 14% of the antipsychotic drugs used in Castile and Leon were used outside of the National Health System.. Appreciable differences exist among the different provinces. CONCLUSIONS: The consumption of antipsychotic drugs in Castile and Leon grew by 146% throughout the twelve months studied. The marketing of new atypical antipsychotic drugs and the legal measures related to the deinstitutionalization of mental patients may have played a major role in this increase. The marketing of the new antipsychotic drugs has led to a change in their pattern of use and has give rise to an rise in the direct costs. The consumption of these medications not charged to the National Health System is minor, but not negligible.
Assuntos
Antipsicóticos/uso terapêutico , Revisão de Uso de Medicamentos/estatística & dados numéricos , Antipsicóticos/economia , Bases de Dados como Assunto , Revisão de Uso de Medicamentos/economia , Humanos , Transtornos Psicóticos/tratamento farmacológico , Transtornos Psicóticos/economia , EspanhaRESUMO
The Spanish regulatory framework for storage of samples for research responds to most issues raised by both researchers and society regarding biobanking. The Spanish regulation currently foresees three possible ways in which these samples are to be handled: (a) gathering for use in a specific project, (b) storage in a collection, and (c) storage in a Biobank. Samples incorporated into a 'collection' can only be used by the investigator who requested them and cannot be transferred to third parties or used in research projects outside the particular research line foreseen in the original consent. On the other hand, the legal entity 'Biobank' refers not only to a set of physical facilities but to the management of the samples stored under that label, and particularly to the requirements for their cession. An approach based on putting most of the regulatory weight on the biobank side has been chosen in order to guaranty the rights of the donors as well as to ease the task of the researchers. A Biobank requires both to be authorized and to be registered in a public Registry. The requirements are quite stringent, allowing for the consent to be given as 'broad' in scope without implying being 'blank.' In this regard, for Biobanks to justify the taking on of some of the donors' rights, a key requirement is to have an external ethics committee supervising the adequacy of samples cession and use, notwithstanding the need for a previous bioethical supervision of the target protocol.
Assuntos
Bioética , Bancos de Espécimes Biológicos/legislação & jurisprudência , Pesquisa Biomédica , Bancos de Espécimes Biológicos/ética , Bancos de Espécimes Biológicos/organização & administração , Órgãos Governamentais , Humanos , Consentimento Livre e Esclarecido , EspanhaAssuntos
Bancos de Espécimes Biológicos/legislação & jurisprudência , Preservação Biológica/métodos , Pesquisa/legislação & jurisprudência , Testes Anônimos/legislação & jurisprudência , Testes Anônimos/normas , Autopsia/normas , Bancos de Espécimes Biológicos/ética , Bancos de Espécimes Biológicos/organização & administração , Ensaios Clínicos como Assunto/legislação & jurisprudência , Confidencialidade/legislação & jurisprudência , Termos de Consentimento/normas , Ética em Pesquisa , Humanos , Consentimento Livre e Esclarecido/legislação & jurisprudência , Direitos do Paciente , Preservação Biológica/ética , Sistema de Registros , Espanha , Manejo de Espécimes/normasRESUMO
OBJECTIVE: During the past few years there have been changes in the availability of opioids in Spain, and new policies on palliative care have been implemented. The aim of this study was to describe the new pattern of opioid consumption in Spain and the associated economic impact. METHODS: A search in the ECOM (Especialidades Consumo de Medicamentos) database of the Ministry of Health and Consumer Affairs for the 1992-2006 period was carried out. This database contains information on prescriptions of primary care medicines that are covered by the National Health System in Spain. RESULTS: Since 1992, overall opioid consumption has increased 14-fold, from 0.3 DDD/1000 inhabitants per day to 4.4 DDD/1000 inhabitants per day. For the six drugs that require a special prescription form--morphine, methadone, oxycodone pethidine, tilidine and fentanyl--consumption increased from 0.1 DDD/1000 inhabitants per day in 1992 to 1.2 in 2006. During this same period, the total costs of these prescriptions increased by 36.8-fold, and the cost per day and per patient doubled. CONCLUSION: A huge increase in opioid consumption has occurred during the time period covered by this study, with fentanyl consumption accounting for most of that increase. Although oral morphine is the first-choice drug among strong opioids, fentanyl is currently the most consumed.
Assuntos
Analgésicos Opioides/uso terapêutico , Fentanila/uso terapêutico , Analgésicos Opioides/economia , Interpretação Estatística de Dados , Prescrições de Medicamentos/estatística & dados numéricos , Uso de Medicamentos , Humanos , Morfina/uso terapêutico , Cuidados Paliativos , Espanha/epidemiologiaRESUMO
No disponible
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Humanos , Manejo de Espécimes/métodos , Bancos de Espécimes Biológicos/organização & administração , Pesquisa Biomédica/tendências , Confidencialidade/normas , Armazenamento de ProdutosRESUMO
No disponible
No disponible
Assuntos
Humanos , Legislação de Medicamentos/normas , Vigilância de Produtos Comercializados/normas , Espanha , Vigilância de Produtos Comercializados/economia , Estudos Prospectivos , Projetos de Pesquisa e Desenvolvimento , Ensaios Clínicos como Assunto/economia , Ensaios Clínicos como Assunto/legislação & jurisprudência , Ensaios Clínicos como Assunto/normas , Comissão de ÉticaRESUMO
Fundamento y objetivo: En julio de 2002, los estudios postautorización de tipo observacional quedaron definitivamente regulados en España. La justificación de dicha regulación ha sido cuestionada. El objetivo de este trabajo es evaluar la calidad científica y ética de los estudios registrados el año previo a la entrada en vigor de la normativa, así como el valor social de sus resultados utilizando su publicación como indicador. Material y método: Se ha recogido los datos de carácter administrativo, metodológico, ético y de seguimiento de los estudios postautorización presentados en la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) durante el año 2001. Resultados: En 2001 se presentó en la AEMPS un total de 162 estudios postautorización que pretendían incluir un total de 306.539 pacientes. El diseño más habitual fue el de «seguimiento prospectivo no controlado» (122 estudios [75%]) y prácticamente en su totalidad (99%) el médico fue la única fuente de información. En un 43% no se especifica el tamaño muestral o no se justifica. La duración de los estudios fue inferior a 12 meses en el 83%. Sólo en el 13% de los estudios se solicitó la revisión por un comité ético de investigación clínica y sólo en el 44% se preveía algún procedimiento de información a los sujetos de investigación. Once estudios se publicaron como originales en revistas (el 10% de los finalizados), 1 de ellos en una revista internacional, y 13 (el 12% de los finalizados) en forma de comunicaciones a congresos, 2 de ellos internacionales. Conclusiones: Los estudios postautorización presentados en la AEMPS durante el año 2001 tuvieron escasa calidad metodológica y ética. La mayoría de ellos no se publicó, lo cual pone en cuestión el valor de esas investigaciones al tiempo que alimenta las dudas sobre su verdadera finalidad. La regulación de esos estudios parecía, pues, justificada
Background and objective: In July, 2002, observational post-authorization studies were subjected to regulation in Spain, giving rise to an uproar among sponsors and investigators. The aim of the present report was to assess the scientific and ethical quality of the studies presented during the year before the regulation came into force. In addition, we explored how many of them reached publication. Material and method: We extracted information relative to administrative procedures, methods, follow-up and ethical issues from the protocol of the studies presented to the Spanish Agency for Medicines and Healthcare Products (AEMPS) during 2001. Results: A total of 162 studies intended to recruit 306,539 patients were registered as post-authorization studies in 2001. The most widely used design was the «non-controlled prospective follow-up study» (122 studies; 75%). Physicians were the only source of information in 99% of the studies. In 43% of them, the sample size was neither specified nor justified. In 83% of the studies the observation period per patient was less than 12 months. An ethical review was requested for only 13% of the studies while a procedure to inform patients was planned in 44%. Eleven studies (10% of those finalized) had been published in scientific journals (1 of them international) and 13 (12% of those finalized) were reported as a communication to a national (11) or international (2) congress. Conclusions: Most post-authorization studies presented to the AEMPS in 2001 had poor methodological and ethical quality. Only a few became published, raising doubts about their scientific aims. These results give empirical support to the regulation adopted
Assuntos
Humanos , Aplicação de Novas Drogas em Teste/legislação & jurisprudência , Comissão de Ética/normas , Vigilância de Produtos Comercializados/normas , Seguimentos , Drogas em Investigação/normas , Qualidade dos Medicamentos HomeopáticosRESUMO
No disponible
Assuntos
Humanos , Legislação de Medicamentos , Bibliometria , Reprodutibilidade dos Testes , Inibidores da Agregação Plaquetária , Estudos Retrospectivos , União Europeia , EditoraçãoRESUMO
El objetivo del presente estudio ha sido conocer la evolución de las tendencias de utilización de insulina y fármacos antidiabéticos orales en España durante la década 1989-1998. Para ello se ha realizado un estudio de utilización de medicamentos longitudinal, descriptivo y retrospectivo que incluyese las especialidades farmacéuticas pertenecientes al grupo Anatómico Terapéutico A10 (antidiabéticos) dispensadas con cargo a la Seguridad Social. El consumo conjunto de insulina y de fármacos antidiabéticos orales ha experimentado un notable incremento durante el periodo estudiado, pasando de 16,02 dosis diarias definidas por 1.000 habitantes y día en 1989 a 32,74 en 1998. En 1998, los dos principios activos más consumidos del grupo fueron la glibenclamida y la acarbosa. La utilización de insulina también ha experimentado un importante incremento, sin embargo, en términos absolutos queda lejos del total de antidiabéticos orales. La aparición de los nuevos sistemas de inyección de insulina y de nuevos antidiabéticos orales como la acarbosa ha podido jugar un papel importante. Un incremento en la prevalencia de esta patología, junto con un mejor diagnóstico y tratamiento de la misma podría explicar una parte del incremento del consumo experimentado por este grupo farmacológico (AU)
The aim of the present study has been to known the trends in the use of insulins and oral antidiabetics in Spain along the period 1989-1998. For this purpose, a longitudinal, descriptive and retrospective study of the use of pharmaceutical products belonging to the anatomical therapeutic group A/0 (antidiabetics) and dispensed at the Social Security expense has been done. Overall insulin and oral antidiabetics consumption has experienced an important increase, from 16.02 defined daily doses per 1,000 inhabitants per day in 1989 to 32.74 in 1998. In 1998, the most utilized medication was glibenclamide and acarbose. Insulin utilization also increased, though, in absolute values, it remained below that of oral antidiabetics. The introduction in Spain of newer systems to deliver insulin and newer oral antidiabetics like acarbose may have played an important role. An increase in the prevalence, along with a better diagnosis and treatment, may explain a part of the increase in consumption experienced by this pharmacological group (AU)
Assuntos
Humanos , Diabetes Mellitus/tratamento farmacológico , Automedicação , Hipoglicemiantes/uso terapêutico , Espanha , Estudos Longitudinais , Estudos Retrospectivos , Insulina/administração & dosagemRESUMO
FUNDAMENTO: El consumo del tratamiento hormonal sustitutivo (THS) en España no se conoce con exactitud. Por este motivo, nos hemos planteado un estudio que permita conocer el consumo cuantitativo del THS, sus características y la prevalencia de uso de esta terapia de sustitución. SUJETOS Y MÉTODO: Para conocer el consumo, se utilizó la información que ofrece la base de datos de medicamentos ECOM del Ministerio de Sanidad y Consumo. También se empleó la información proveniente de una encuesta a mujeres a las que fue prescrito THS por los médicos pertenecientes a la Red de Médicos Centinelas de Castilla y León. Los datos de consumo se presentan en dosis diarias definidas por 1.000 mujeres con más de 40 años por día (DHD); se estimó también la prevalencia de uso por año y por grupos de edad. RESULTADOS: El consumo de THS en España a través de Sistema Nacional de Salud pasó de 6,94 dosis diarias definidas (DDD) por 1.000 mujeres mayores de 40 años en 1989 a 39,92 en 1999. El porcentaje de mujeres mayores de 40 años que usaban THS pasó del 0,7 por ciento en 1989 al 3,4 por ciento en 1999; el grupo de edad 50-54 años, con el 10,8 por ciento (intervalo de confianza del 95 por ciento, 10,7-11,0), fue el de mayor consumo. Los síntomas de la menopausia fueron el motivo más frecuente de prescripción de esta medicación. En la mitad de los casos se prescribieron estrógenos solos. CONCLUSIONES: La introducción en el mercado de las formas transdérmicas de administración de THS propició un aumento del consumo; no obstante, la proporción de mujeres posmenopáusicas que reciben THS en España es baja si se compara con la de otros países. La proporción de terapia combinada de estrógenos y progestágenos es igualmente baja si tenemos en cuenta las recomendaciones para su empleo. (AU)